Sterile Processing

The Food and Drug Administration (FDA) has issued a communication to healthcare professionals to share preliminary information regarding infections associated with the use of reprocessed flexible bronchoscopes.

Researchers from the University of Southampton have demonstrated how a pioneering ultrasonic device can significantly improve the cleaning of medical instruments and reduce contamination and risk of infection.

Q: Our facility has been using rigid sterilization containers for some time. We do not have a cart washer or mechanical washer so we wipe them out with a disinfectant wipe. I attended a webinar and was told this is not accepted practice. We have been cleaning the containers this way for years. What is the correct practice?

The Association for the Advancement of Medical Instrumentation (AAMI) recently held a roundtable discussion on the numerous challenges associated with sterile processing.

“Can’t you just hand-wash that piece of equipment and put it in the sterilizer?”That’s one question Tim Brooks hears often-especially from surgeons.The answer is usually, “No.”“I don’t think people really understand what it takes to get instruments back on the shelf,” says Brooks, BS, CSPM, senior manager of sterile processing at Banner University Medical Center in Tucson, Ariz. “Many doctors have no idea what the functions of the sterile processing department (SPD) are. The only real exposure they have is what they’ve been told by scrub techs and nurses in the OR suite. In my 28-plus years in this industry, I’ve only seen three surgeons come and walk through SPD. There is a standard of care for every patient. Every time we make an exception, we are changing things for the next patients.”

In mid-May, the Food and Drug Administration (FDA) convened a special meeting of the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee as a continuance of its examination of end-user challenges associated with reprocessing endoscopes including duodenoscopes. In previous communications, the FDA has expressed its concerns regarding the risks to patients if flexible endoscopes and their accessories are not cleaned properly and reprocessing guidelines not followed. The agency has also held several stakeholders' meetings and workshops, including with the Association for the Advancement of Medical Instrumentation (AAMI) that focused on factors affecting reprocessing of reusable medical devices and established clarion themes that began to outline key challenges and priority actions. In addition, in mid-March, the FDA issued its Final Guidance that addressed mandates for manufacturers relating to validation methods and labeling of medical devices that are reprocessed.

The Association for periOperative Registered Nurses (AORN) is currently updating its guideline on flexible endoscope reprocessing. ICT spoke with Sharon Van Wicklin, MSN, RN, CNOR, CRNFA(E) CPSN-R, PLNC, a perioperative nursing specialist for AORN who is responsible for this undertaking. She shares her thoughts about the opportunities and challenges associated with revising a guideline of this magnitude.